NCT05930379

A Feasibility Pilot Study on Lee Silverman Voice Treatment-Loud: a Telerehabilitation Approach

Completed NA Last updated 4 September 2025

What this trial tests

NA trial testing LSVT-Loud delivered by telerehabilitation in Multiple Sclerosis in 20 participants. Completed in 1 September 2024.

Timeline

10 June 2023

Primary endpoint
1 September 2024

1 September 2024

Quick facts

Lead sponsor	Fondazione Don Carlo Gnocchi Onlus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	10 June 2023
Primary completion	1 September 2024
Estimated completion	1 September 2024
Sites	1 location across Italy

Drugs / interventions tested

• LSVT-Loud delivered by telerehabilitation
• LSVT-Loud in the clinic

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Fondazione Don Carlo Gnocchi Onlus — full company profile →

Who can join

Adults 18 to 85, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multiple Sclerosis (MS) is one of the most common causes of neurological disability in young adults. At least 62% of people with MS have speech, vocal, or communication disorders. Among these, alterations in voice intensity and quality constitute a limitation in MS people's social life leading to experience difficulties in work, conversations, and communication especially in noisy environments or through the telephone. Though voice and speech impairments and speech impairments are widely prevalent in this population, only 2% of the people receive speech therapy. The Lee Silverman Voice Treatment (LSVT)-Loud is a well-documented, efficacious intensive speech intervention, for treating hypophonia in subjects with neurological conditions. Despite the effectiveness of LSVT-Loud treatment on the voice has been reported in MS, several factors prevent the agile use of this method in rehabilitation centers: motor disability, work commitments, and distance barriers may preclude repeated attendance of this intervention at a healthcare facility. Telerehabilitation represents a feasible solution to bypass these potential barriers related to attendance at the rehabilitation programs in the clinic. The increasing evidence sustains the role of telerehabilitation for the migration of care from the clinic to the patient's homes, overcoming several obstacles affecting service accessibility. Previous studies showed the validity and the non-inferiority of LSVT-Loud delivered via telerehabilitation in subjects with Parkinson's Disease, while no pieces of evidence are still available on the efficacy of voice treatment delivered by telerehabilitation in MS. It is plausible to assume that LSVT-Loud delivered by telerehabilitation would be feasible and provide a beneficial effect also for MS non-inferior compared to the same treatment delivered in the clinic.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Telerehabilitation for Lee Silverman Voice Treatment (Tele-LSVT)-Loud on voice intensity and voice use in daily living in people with multiple sclerosis: A protocol for a feasibility and pilot randomized controlled study.
   Vitali C, Fusari G, Baldanzi C, Cacciatore DM, et al · · 2023 · cited 2× · PMID 38074343 · DOI 10.1177/20552076231218150
2. Delivering the Lee Silverman voice treatment-loud method in-site versus telerehabilitation in people with multiple sclerosis: Feasibility evidence of a non-inferiority pilot randomized controlled trial.
   Vitali C, Fusari G, Cacciatore DM, Smecca G, et al · · 2025 · PMID 40433301 · DOI 10.1177/20552076251326222